Pharmacokinetics in Stable Kidney Transplant Recipients After Conversion From Twice-Daily to Once-daily Tacrolimus Formulations

被引:42
作者
van Hooff, Johannes [2 ]
Van der Walt, Isak [3 ]
Kallmeyer, Jeffrey [4 ]
Miller, Derek [5 ]
Dawood, Shabbir [4 ]
Moosa, M. Rafique [6 ,7 ]
Christiaans, Maarten [2 ]
Karpf, Carmen [8 ]
Undre, Nasrullah [1 ]
机构
[1] Astellas Pharma Europe Ltd, Staines TW18 3AZ, Middx, England
[2] Univ Hosp, Dept Internal Med, Subdiv Nephrol, Maastricht, Netherlands
[3] Jacaranda Hosp, Pretoria, South Africa
[4] St Augustines Hosp, Chelmsford Med Ctr, Durban, South Africa
[5] Christiaan Barnard Mem Hosp, Cape Town, South Africa
[6] Univ Stellenbosch, Dept Med, Cape Town, South Africa
[7] Tygerberg Hosp, Cape Town, South Africa
[8] Astellas GmbH, Munich, Germany
关键词
kidney; once-daily tacrolimus; prolonged-release; tacrolimus; transplant; therapeutic drug monitoring; SOLID-ORGAN TRANSPLANTATION; PROGRAF-BASED REGIMEN; CYCLOSPORINE;
D O I
10.1097/FTD.0b013e318244a7fd
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Background: A prolonged-release formulation of tacrolimus for once-daily administration (Tacrolimus QD) has been developed to offer potential improvements in patient adherence. This study compared the pharmacokinetics (PK) of tacrolimus in stable kidney transplant recipients before and after conversion from twice-daily tacrolimus (Tacrolimus BID) to Tacrolimus QD. Methods: This was an open-label, multicenter replicate design study in stable adult kidney transplant recipients (>= 6 months post-transplantation) maintained on Tacrolimus BID. Patients underwent four sequential 14-day treatment periods of alternating Tacrolimus BID and QD (mg:mg conversion). Four 24-hour PK profiles were collected, one on the last day of each treatment period. Adverse events were also reported. Results: A total of 60 of 69 patients completed all 4 PK profiles. Steady-state tacrolimus area under the curve from 0 to 24 hours and Cmin were comparable for both formulations, with treatment ratio means (90% confidence intervals) of 92.9% (89.8%-96.0%) and 90.9% (87.3%-94.6%), respectively (acceptance interval: 80%125%). Both formulations were well tolerated, with renal function remaining stable over the 8-week period. There was a good correlation between area under the curve from 0 to 24 hours and Cmin for Tacrolimus QD and BID (r = 0.88 and 0.82, respectively). The relationship between these two parameters was also similar. Conclusions: The results of this study provide evidence for safe conversion from Tacrolimus BID to QD with appropriate trough concentration monitoring.
引用
收藏
页码:46 / 52
页数:7
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